Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors

NCT04989010 | Unknown

• 1 other identifier: LS-CLDN18.2 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (3)

• Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005)

  Biodistribution of 89Zr-Anti-CLDN18.2 mAbs (NY005) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 89Zr-PET scans will be reported.

  1 year

• Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005).

  Area under the radioactivity (SUVs) versus time (time from injection) curve (AUC) will be derived by integration and reported. Other pharmacokinetic parameters including peak radioactive uptake (Cmax) and time (Tmax) in different organs, clearance and volume of distribution, evaluated using a biexponential model and non-compartmental analysis, will be reported.

  1 year

• Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005).

  Absorbed dose (radioactive uptake) estimates for different organs and tissues calculated with the AUCs and the OLINDA/EXM dosimetry program will be obtained and reported.

  1 year

Study Arms (1)

89Zr-NY005 injection

EXPERIMENTAL

Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3 mCi) labeled anti-CLDN18.2 mAbs (89Zr-NY005)

Drug: 89Zr-NY005

Interventions

89Zr-NY005 DRUG

89Zr-NY005 injection followed by 89Zr-NY005 PET scan

89Zr-NY005 injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;
• Aged 18-80, male or female;
• The clinical diagnosis was gastric cancer, esophageal cancer and pancreatic cancer;
• Patients with biopsy-proven CLDN18.2 positive;
• Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
• At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
• ECOG score ≤ 0\~3; Life expectancy of at least 3 months;
• ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.
• Other routine examinations are within the normal range or considered acceptable by the researchers.

You may not qualify if:

• Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
• Patients with systemic or locally severe infections, or other serious coexisting diseases;
• Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
• Patients with autoimmune diseases, including rheumatoid arthritis;
• Inadequate control of arrhythmias, including atrial fibrillation;
• Uncontrolled hypertension;
• Patients with allergies or allergies to any component of the imaging agent or antibody;
• Patients who cannot undergo PET/CT imaging scan;
• Syphilis, HBV, HCV, or HIV positive subjects;
• Male and female subjects of reproductive age cannot take effective contraceptive measures;
• Pregnant or lactating women;
• Patients with a history of mental illness or related conditions;
• Other subjects considered unsuitable by researchers.

Sponsors & Collaborators

• Wuxi No. 4 People's Hospital: lead

Study Sites (1)

Wuxi No. 4 People's Hospital

Wuxi, Jiangsu, 214062, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 4, 2021
• Study Start: August 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)